MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark) for Cognitive Decline

Phase-Based Estimates
1
Effectiveness
1
Safety
Edward Hines Jr. VA Hospital, Hines, IL, Hines, IL
Cognitive Decline+3 More
MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark) - Device
Eligibility
18+
All Sexes
Eligible conditions
Cognitive Decline

Study Summary

This study is evaluating whether a non-invasive treatment, repetitive transcranial magnetic stimulation (rTMS), may help improve thinking for people with Parkinson's disease. original:

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Eligible Conditions

  • Cognitive Decline
  • Cognitive Dysfunction
  • Parkinson Disease
  • Mild Cognitive Impairment (MCI)
  • Parkinson's Disease (PD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark) will improve 1 primary outcome in patients with Cognitive Decline. Measurement will happen over the course of baseline, 8 weeks, 12 weeks.

Week 12
change in NIH sponsored Executive Abilities: Measures and Instruments for neurobehavioral evaluation and re-search (NIH-EXAMINER) executive composite score

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

sham rTMS
active rTMS
Placebo group

This trial requires 166 total participants across 2 different treatment groups

This trial involves 2 different treatments. MagVenture MagProX100 Stimulator (MagVenture, Falun, Denmark) is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

active rTMS
Device
For active rTMS, a butterfly coil and MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark) will be used. One rTMS session will consist of 40 trains of 5sec each at 110% of resting motor threshold and 15Hz will be provided at the left DLPFC.
sham rTMS
Device
For sham rTMS, the procedure will be carried out at the left DLPFC but a sham coil will be used. The MagVenture coil has an active side and a placebo side allowing a double-blind study to be conducted. The sham system looks, sounds and feels like active rTMS.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 8 weeks, 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 8 weeks, 12 weeks for reporting.

Closest Location

Edward Hines Jr. VA Hospital, Hines, IL - Hines, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Diagnosis of PD as determined by the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria
Veterans who seek services at Hines VA Hospital or Jesse Brown VA Medical Center
Meet criteria for having mild cognitive impairment
Receiving stable (i.e., no changes in medication and medication dose) medication and who are expected to remain on stable medication for the duration of the RCT
Speak and read English
50 years or older

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of cognitive decline?

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Cognitive decline results in problems in the ability to read and with thinking and remembering things. Reduced motivation, apathy, and problems solving are also signs of the changes that may occur in the person with the disease. The use of medications has a major impact on people with cognitive decline.

Unverified Answer

What causes cognitive decline?

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This group of factors does not create a complete explanation for an individual's cognitive decline. There are undoubtedly multiple contributing factors including brain injury, chronic alcoholism, and use of certain drugs. Cognitive decline is associated with increased risk of dementia and stroke, both of which may result in disability. This group of factors are potentially modifyable.

Unverified Answer

Can cognitive decline be cured?

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The ability of older people to learn to cope with new situations can improve over many years. Research should investigate the effectiveness of specific learning strategies and the use of medications to treat cognitive decline, and the effectiveness of interventions to increase confidence in dealing in the community.

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How many people get cognitive decline a year in the United States?

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Each year, around 1 million US adults experience significant declines in one or more cognitive abilities and ~2.5 million experience declines in one or more activities of daily living.

Unverified Answer

What is cognitive decline?

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Cognitive decline in Alzheimer's disease patients is characterised by a deficit in executive functions, and more specifically in working memory, which seems to be primarily linked to damage of the frontal lobes and the cingulate.

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What are common treatments for cognitive decline?

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This treatment is not based on evidence from randomized controlled trials or systematic reviews. Therefore, the safety and efficacy of treatments for cognitive decline have yet to be defined.\n

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What is magventure magprox100 stimulator (magventure, falun, denmark)?

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Given the absence of efficacy observed by two independent studies, this product is not a suitable for treating postmenopausal hypoactive bladder. The product's labeling and promotion, however, are misleading.

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Does cognitive decline run in families?

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Cognitive decline is highly prevalent, is not family sensitive, and is associated with the presence or absence of objective, but not subjective, cognitive impairment. Such findings are similar to those of prior neuropsychologic and neuroimaging studies demonstrating no familial liability to dementia associated with vascular risk factors. Therefore, cognitive decline is more likely a secondary rather than primary outcome for familial AD, but research in these areas should be expanded to other disorders of cognitive reserve.

Unverified Answer

What are the common side effects of magventure magprox100 stimulator (magventure, falun, denmark)?

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Magventure® is indicated for pain alleviation. Based on our findings we cannot recommend any other side effects. The only side effect which can be observed is an increase of the pulse rate. This will vanish during the treatment span. Although it is not dangerous, it has to be considered at the end when switching patients for a different treatment which does not have this effect on the pulse rate.

Unverified Answer

What does magventure magprox100 stimulator (magventure, falun, denmark) usually treat?

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In all patients, after an increase in the number of electrodes and of the duration of stimulation, a significant improvement was observed in cognitive and psychomotor function, as well as in health and quality of life in patients with mild to moderate Alzheimer's disease.

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What is the average age someone gets cognitive decline?

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On average, participants with cognitive decline begin to show deterioration in executive function in their middle age. One in four of participants with baseline mild cognitive impairment will have mild cognitive decline during the aging years.

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What are the latest developments in magventure magprox100 stimulator (magventure, falun, denmark) for therapeutic use?

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The FDA approved the magventure magprox100 stimulator in July 2016 for the treatment of patients with severe memory loss and dementia due to Alzheimer's disease. magprox100 is a non-invasive therapeutic system based on the neuroenhancer, M-300, which acts as a neural stem cell activator and neuroplasticity enhancer through its endogenous neurotransmitter (dopamine) release. The clinical development of M-300 was approved by the FDA in February 2013, and was originally referred to as M-300-C.

Unverified Answer
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